Key takeaways
- Despite state ballot initiatives that supported access to abortion, a Trump administration may move swiftly to restrict abortion on nationwide basis, especially medication abortion.
- We believe that while it is unlikely that a federal abortion ban will be implemented, it is certain that alternative restrictive strategies will be implemented or facilitated by a Trump administration.
- A Trump FDA is likely to severely restrict access to or remove the only approved abortion drug (mifepristone) from the market.
- A Trump DOJ may signal enforcement of the Comstock Act to prohibit distribution of abortion drugs via mail and common carriers.
- A Trump HHS will likely reverse EMTALA policies related to emergency abortions in hospitals and may create new policies characterizing the unborn as “persons” under EMTALA.
The 2024 election results are coalescing, and one thing is certain: for the future of reproductive rights, there is a lot of uncertainty. From abortion-related ballot initiatives to the incoming Trump administration’s plans for regulating medication abortions, there will likely be a lot of upheaval in the coming year.
The most immediate impact will be felt from the state ballot initiatives, which, once certified, will result in major changes to state abortion laws in most of the affected jurisdictions. For example, citizens in Missouri, which currently operates under some of the country’s most severe restrictions on abortion (who voted for the Republican presidential ticket) passed a constitutional amendment to protect reproductive freedoms. Florida, on the other hand, narrowly fell short of passing a constitutional amendment to protect abortion access, suggesting perhaps an opportunity to try again when the measure is not tied to such a significant election.
The Project 2025 plan for the Trump administration (published by the Heritage Foundation in 2023) contains a section written by Roger Severino, the attorney who led the U.S. Department of Health and Human Services Office for Civil Rights during Trump’s last term.
Key among the post-election considerations are the plans for how to handle the current dispute over the Food and Drug Administration’s approval of mifepristone and its risk evaluation and mitigation strategy (REMS) program, the potential impact of EMTALA on abortion providers in states that have near-total abortion bans (e.g., Idaho) and possible enforcement of the Comstock Act against companies that ship the medication across state lines. A lot of that will also depend on whom Trump picks to fill the key posts of FDA Commissioner and HHS Secretary.
State ballot initiatives
Reproductive rights advocates saw a significant success in the 2022 midterm elections with the passage of constitutional amendments to protect abortion access and the failure of other measures to restrict abortion. With that backdrop, it was no surprise that ultimately, 11 ballot initiatives spread out over 10 states (Nebraska had two competing initiatives) made it on to the 2024 ballots. When the dust settled after election night, 8 of the 11 initiatives had passed, with 6 of the states now including some protections for abortion in their state constitutions. Whether this successful strategy will have long-term consequences in protecting reproductive rights remains to be seen.
States without pre-viability abortion restrictions
Four states that didn’t have abortion restrictions pre-viability, or had previously passed laws that protected abortion rights, entertained ballot initiatives in 2024 that went further by either explicitly or arguably making the right to an abortion a part of their state constitutions. Three of those states (Colorado, Maryland, New York) were able to successfully pass their amendments. Meanwhile, the fourth state (Nevada) took its first step toward approving an amendment. The Nevada amendment was approved, but under state law, it must go through one more general election before it is fully approved.
- Colorado – Added Section 32 to Article II of the state constitution, which states: “The right to abortion is hereby recognized. Government shall not deny, impede, or discriminate against the exercise of that right, including prohibiting health insurance coverage for abortion.” Importantly, the amendment places no gestational limit on the right to an abortion, which aligns with current state law.
In addition, the initiative repealed Section 50 of Article V of the state constitution which had been in the state constitution since 1984 and had previously forbidden the state and local governments from using public funds for abortion. This will open the door to permit abortion services to be covered under Health First Colorado, the state’s Medicaid program.
- Maryland – Added Article 48 to the state Declaration of Rights the following: “That every person, as a central component of an individual’s rights to liberty and equality, has the fundamental right to reproductive freedom, including but not limited to the ability to make and effectuate decisions to prevent, continue or end one’s own pregnancy. The state may not, directly or indirectly, deny, burden, or abridge the right unless justified by a compelling state interest achieved by the least restrictive means.” As with Colorado, Maryland’s amendment contained no gestational limit on the right to an abortion. However, unlike Colorado, Maryland state law currently restricts abortion access post-viability.
- New York – Added language to Section 11, of Article 1 of the state constitution, which, among other things, provides that no person would be denied equal protection of state or local law or be subject to discrimination in their civil rights on the basis of “pregnancy, pregnancy outcomes, and reproductive healthcare and autonomy.” While this provision did not specifically entrench abortion rights into the state constitution, proponents of the amendment argued that it would prevent the state legislature from restricting abortion pre-viability.
- Nevada – Took the first step toward approving an amendment that would add Section 25 to Article 1 of the state constitution that would read: “All individuals shall have a fundamental right to abortion performed or administered by a qualified health care practitioner until fetal viability, or when needed to protect the life or health of the pregnant patient, without interference from the state or its political subdivisions. The right established by this section shall not be denied, burdened, or infringed upon unless justified by a compelling state interest that is achieved by the least restrictive means.”
States with existing abortion restrictions that adopted abortion protections
Six states that had pre-viability abortion restrictions in place and/or had recently passed abortion restrictions that were in various stages of court challenges also entertained ballot initiatives. In three of those states (Arizona, Missouri, Montana), voters passed measures that will add protections for abortion rights to their state constitutions.
- Arizona – Added Article 2, Section 8.1 to the state constitution: “Every individual has a fundamental right to abortion, and the state shall not enact, adopt or enforce any law, regulation, policy or practice that does any of the following: 1. Denies, restricts or interferes with that right before fetal viability unless justified by a compelling state interest that is achieved by the least restrictive means. 2. Denies, restricts or interferes with an abortion after fetal viability that, in the good faith judgment of a treating health care professional, is necessary to protect the life or physical or mental health of the pregnant individual. 3. Penalizes any individual or entity for aiding or assisting a pregnant individual in exercising the individual’s right to abortion as provided in this section.”
Immediately after the Dobbs decision, Arizona had enacted a law that restricted abortion after 15 weeks. Subsequently, in 2024, the state supreme court ruled that an old territorial law from 1864 that banned abortion completely was still effective. The state legislature quickly took action after the ruling to repeal the 1864 statute but left the 15-week ban in place. Under the terms of the new constitutional amendment, we are likely to see litigation in the state courts seeking a declaration that the 15-week ban is unconstitutional, but until that time, or until the legislature repeals the statute, the law will remain on the books. Additionally, we may see legal challenges to other abortion laws currently in place, including the Ariz. Rev. Stat. section 36-2160, which establishes that abortion-inducing drugs may only be “provided” by physicians, which currently operates to restrict pharmacies from dispensing abortion-inducing drugs.
- Missouri – Added Section 36 to Article I of the state constitution that reads in relevant part: “The Government shall not deny or infringe upon a person's fundamental right to reproductive freedom, which is the right to make and carry out decisions about all matters relating to reproductive health care, including but not limited to prenatal care, childbirth, postpartum care, birth control, abortion care, miscarriage care, and respectful birthing conditions.” This language permits abortion restrictions in the state only if they serve a compelling interest and for the “limited purpose and has the limited effect of improving or maintaining the health of a person seeking care, is consistent with widely accepted clinical standards of practice and evidence-based medicine and does not infringe on that person's autonomous decision-making.”
The provision also permits the state to enact laws “that regulate the provision of abortion after Fetal Viability provided that under no circumstance shall the Government deny, interfere with, delay, or otherwise restrict an abortion that in the good faith judgment of a treating health care professional is needed to protect the life or physical or mental health of the pregnant person.” Additionally, the amendment prohibits penalties and prosecution of individuals both for the exercise of their right to an abortion and for assisting someone in exercising their right to an abortion.
Immediately after the Dobbs decision, a Missouri law went into effect that banned abortion with only an affirmative defense for abortions performed pursuant to a medical emergency. This new amendment would seem to make that statute unconstitutional; Planned Parenthood has already filed court challenges asserting just that.
- Montana – Added Section 36 to Article II of the state constitution that reads: “There is a right to make and carry out decisions about one’s own pregnancy, including the right to abortion. This right shall not be denied or burdened unless justified by a compelling government interest achieved by the least restrictive means.” The provision sets a gestational limit on the right, allowing the government to restrict abortion after fetal viability as long as the restriction does not inhibit a medically necessary abortion.
Like the Missouri amendment, this amendment also prevents the government from prosecuting or penalizing anyone for exercising their right or assisting another in doing so.
In Montana, a 2012 decision by a state court to enjoin a parental consent law relating to abortion was upheld by the state supreme court in 2023, finding that the law violated the right to privacy in the state’s constitution. This decision and earlier decisions by the state supreme court inferred the right to bodily autonomy into the state constitution’s right of privacy. This amendment directly includes that in its own provision of the state constitution.
States with restrictions that failed to adopt protections or adopted further limits
Three states (Florida, Nebraska, South Dakota) had provisions on the ballot that would have enshrined the right to an abortion in the state’s constitution. All three failed to reach the needed votes to succeed. There was a competing provision in Nebraska – which did pass – that limits abortions to the first trimester.
- Florida – The ballot initiative would have added a new section to Article I of the state constitution and would have explicitly prohibited state and local lawmakers from enacting a law that would “prohibit, penalize, delay, or restrict abortion before viability or when necessary to protect the patient’s health as determined by the patient’s healthcare provider.” The ballot initiative needed to obtain 60% of the vote in order to be approved. It received only 57.1% of the vote.
Florida enacted a “heartbeat law” in 2023 that recently went into effect and prohibits abortion after a fetal heartbeat is detectable, around six weeks gestation. As a result of the failure of the ballot initiative, the heartbeat law will continue to be in effect in the state. It is worth noting that the margin of failure in Florida was narrow, and it remains to be seen whether that will be a signal to reproductive rights advocates to potentially revisit that initiative outside of a presidential election.
- Nebraska – Nebraska had competing ballot initiatives in the 2024 election. In order for one of the initiatives to succeed, it had to do all of the following: (1) be approved by more than 50% of the voters who voted on that initiative, (2) have more than 35% of the total ballots cast in the election voting for it, and (3) receive a higher percentage of votes than the competing ballot initiative.
Initiative 439 would have added Section 31 to Article I of the state constitution and would have established a “fundamental right to abortion until fetal viability or when needed to protect the health and life of the pregnant patient.” It fell short in the first test, only getting a 48.66% positive vote.
Initiative 434 amended Article I to add the following sentence: “Except when a woman seeks an abortion necessitated by a medical emergency or when the pregnancy results from sexual assault or incest, unborn children shall be protected from abortion in the second and third trimesters.” This initiative passed, getting 55.3% positive votes, automatically accomplishing both the first and third tests noted above. Additionally, the initiative received more than 496,000 votes, more than 54% of the approximately 900,000 ballots cast in the state.
Nebraska currently has a 12-week ban in place that includes exceptions for the life of the pregnant patient and for cases of rape and incest. This constitutional amendment allows the legislature to go even further and enact restrictions earlier in pregnancy (such as a heartbeat law) or a total ban, should there be the political will to do so.
- South Dakota – The ballot initiative would have added a new section to Article VI of the state constitution to read: “Before the end of the first trimester, the State may not regulate a pregnant woman's abortion decision and its effectuation, which must be left to the judgment of the pregnant woman. After the end of the first trimester and until the end of the second trimester, the State may regulate the pregnant woman's abortion decision and its effectuation only in ways that are reasonably related to the physical health of the pregnant woman. After the end of the second trimester, the State may regulate or prohibit abortion, except when abortion is necessary, in the medical judgment of the woman's physician, to preserve the life and health of the pregnant woman.”
Because the ballot initiative failed, South Dakota’s multiple abortion bans remain in effect. There is a complete ban on abortion in effect with only an exception to preserve the life of the pregnant person.
As has been the case since the Dobbs decision was handed down in June 2022, there exists a patchwork of abortion laws and regulations across the country, ranging from complete restrictions on the provision of abortion with very narrow exceptions in states that provide full protections for the right to have an abortion, with no legal restrictions.
To date, 10 states now include some explicit abortion protections in their constitutions (Arizona, California, Colorado, Maryland, Michigan, Missouri, Montana, Ohio, New York, Vermont); two states have included abortion restrictions directly into their state constitutions (Florida and Nebraska), and four states have included language that specifically disclaims any constitutional right to an abortion (Tennessee, West Virginia, Alabama, Louisiana).
Adding to the complexity of the landscape of state abortion regulations is the continuing fight over the methods of abortion, in particular the regulation of medication abortion pills.
National abortion legislation and executive action
Federal abortion law
During the 2024 presidential campaign, there was discussion on both tickets about federal action with respect to abortion – including calls for a nationwide ban of abortion by the Republicans, and talk of restoring Roe v. Wade by the Democrats. Any federal law would require 60 votes in the Senate unless the filibuster is removed. Vice President Harris promised that she would support removal of the filibuster for purposes of enacting a national reproductive rights protection law, however, President-elect Trump did not publicly make any similar commitments regarding the removal of the filibuster.
To the contrary, President-elect Trump indicated that he would veto a federal abortion ban, stating that he believes this is an issue that should be left to the states. Campaign promises are, of course, often broken, but we think it is less likely that Trump would change course on this, given the very public nature of such a ban. It is our view that anti-abortion advocates would pursue secondary avenues to restrict abortion that may be more successful in a Trump administration, specifically changes to FDA’s approval of medication abortion and the ability for retail pharmacies to dispense such drugs.
Mifepristone approval
Mifepristone, the primary pharmaceutical used in medication abortion, was approved by FDA in September 2000 under the brand name Mifeprex. In the intervening 24 years, FDA has placed risk evaluation and mitigation strategy (REMS) restrictions on the dispensing of the drug that initially included requirements for in-person consultation and dispensing by the prescriber, multiple follow-up visits and adverse reaction reporting. FDA also approved a generic version of the pill under the same REMS restrictions. After the pandemic, FDA modified the REMS to remove the in-person consultation and dispensing requirements and to expand the certification program to allow retail and mail-order pharmacies to dispense the drugs.
Court challenges to mifepristone approval
Shortly after the Dobbs decision was handed down, an organization that represented physicians with religious objections to abortion sued in federal court seeking to have that approval withdrawn. The case, Alliance for Hippocratic Medicine v. FDA, resulted in a decision by Judge Kacsmaryk of the U.S. District Court for the Northern District of Texas that would have stayed FDA’s initial approval of Mifeprex, which would have effectively forced the drug manufacturer to stop marketing it until the case was concluded and FDA revisited its approval process.
That decision made its way to the U.S. Supreme Court, which ultimately decided that the plaintiffs did not have standing to bring the case. The case was reversed and remanded in a way that could result in its ultimate dismissal. Under a Trump administration, that court case, which continues to this day in the district court as three intervenor states are seeking to amend the complaint in an attempt to circumvent the standing hurdle, might be moot as whomever takes over at FDA could order the approval of the drug withdrawn.
Project 2025 goals for mifepristone
During the presidential campaign, there were conflicting messages about whether the document known as “Project 2025” reflected the expected policy goals of a potential Trump administration. The candidate himself disavowed it, but it was written in large part by former members of his first administration and was touted by the Heritage Foundation as a blueprint for the next Republican presidential administration.
Within the section of Project 2025 that governs the Department of Health and Human Services, the authors advocate for FDA to withdraw its approval of mifepristone. However, noting that such a withdrawal would take time, the document calls for FDA, as an interim step, to reinstate the REMS conditions as they existed prior to the pandemic and require in-person dispensing and consultation.
The future of mifepristone availability in large part depends on the recommendations of whomever Trump selects to be FDA Administrator as well as the results of any proposed agency cutbacks that were floated during the campaign. With that in mind, we think it is likely that the mifepristone REMS could be reevaluated (including a decision to eliminate retail pharmacy dispensing) and it is possible that FDA could consider changes to the approval of the drug itself.
The Comstock Act
The Comstock Act is a 19th century law that prohibits, among other things, the distribution through the mail (or in interstate commerce via common carrier) devices and drugs intended to help effectuate an abortion. The law has not been enforced, however, for over half a century.
After the Dobbs decision, in December 2022, the DOJ’s Office of Legal Counsel issued an opinion to the General Counsel of the U.S. Postal Service indicating its position that the Comstock Act does not prohibit the mailing of mifepristone and its companion drug, misoprostol, for the purposes of performing an abortion as long as the shipper does not intend for the drugs to be used unlawfully. That reflects the differences in state laws and indicates, according to DOJ, that as long as the manufacturer and distributor are not shipping the drugs to states where medication abortion has been outlawed, their distribution through the U.S. Postal Service and common carriers does not violate the Comstock Act.
Opponents of abortion have argued that the Comstock Act could be revived to prevent the distribution of abortion medications throughout the country. Justice Clarence Thomas, for example, inquired about the applicability of the law during oral argument before the Supreme Court in Alliance for Hippocratic Medicine v. FDA.
The Project 2025 document urges the next presidential administration to enforce the Comstock Act against the manufacturers and distributors of mifepristone, stating specifically that a new administration should “stop promoting or approving mail-order abortions in violation of long-standing federal laws that prohibit the mailing and interstate carriage of abortion drugs.” The document does not go into further detail, however, and the question for an incoming U.S. Attorney General would be whether simply withdrawing the opinion of the Office of Legal Counsel is sufficient warning to cause the manufacturers and distributors to stop shipping the drugs nationwide, or if they would have to attempt to enforce the law. While there are arguments around the applicability of the law to typical drug distribution arrangements, our view is that circumstances surrounding any withdrawal of the opinion would likely have to be considered and could potentially have a chilling effect on the distribution chains involving medication abortion drugs.
EMTALA and HIPAA
There are two more aspect of reproductive health care that could be impacted by the incoming Trump administration as well. These include recent executive actions involving the Emergency Medical Treatment and Labor Act (EMTALA) and the HIPAA Privacy Rule that sought to strengthen abortion protections even in states that have enacted bans and other restrictions.
Using EMTALA to restrict abortion
In the immediate aftermath of the Dobbs decision, the Biden administration leaned on EMTALA to require hospitals to provide emergency abortion care to patients even in states with abortion bans. EMTALA is an anti-patient-dumping law that requires any hospital with an emergency room, when faced with a patient in a medical emergency, to properly evaluate that patient’s condition and to provide sufficient care to stabilize the patient before the hospital can even consider releasing or transferring the patient, notwithstanding a patient’s inability to pay for the stabilizing treatment.
The Biden HHS issued guidance asserting that EMTALA required clinicians to provide emergency abortion care to pregnant patients in need. A group of physicians and the state of Texas challenged that guidance and obtained an injunction against HHS that resulted in the guidance not being applicable in Texas or against those organizations. It is safe to assume that a Trump administration will rescind this guidance.
Additionally, the Biden DOJ sued the state of Idaho, arguing that an Idaho abortion law violated EMTALA and was thus superseded by the federal law. While federal district court enjoined the Idaho law pending resolution of the case and the U.S. Supreme Court refused to consider an appeal of that injunction, the case is still currently pending on remand to the 9th Circuit, so it is not yet clear whether EMTALA requires even an abortion-restricting state to provide emergency abortion care.
But the new Trump administration may use EMTALA from another angle to prosecute providers even in states that have provided protections for abortion. According to the Project 2025 document, EMTALA “mandates that hospitals stabilize pregnant women and explicitly protects unborn children.”
According to that document, EMTALA violations are committed by individuals who fail to protect unborn children when faced with an emergency situation, and those violations should be enforced. Specifically, the document says that HHS should “use EMTALA and Section 504 of the Rehabilitation Act, which prohibits disability discrimination, to investigate instances of infants born alive and left untreated in covered hospitals." The Project 2025 framework would essentially read personhood standards into federal guidance in a way that was not previously contemplated by EMTALA. Given the complexity of federal law and state practice of medicine issues, this is a potentially significant area to watch as the incoming administration announces its policies.
HIPAA Privacy Rule on reproductive health
Another way that a Trump administration may be able to impact reproductive health in states that have approved protections for abortion would be through the repeal of the Reproductive Health Privacy Rule.
The rule, issued in April 2024, prohibits covered entities in possession of protected health information from disclosing that information to authorities seeking to investigate whether an individual had an abortion that is lawful in that state in which it is obtained. The rule would effectively give physicians in states where abortion is legal a federal framework that they could point to when approached by civil or criminal authorities from abortion-banning states seeking information about that state’s citizens who may have traveled across state lines for an abortion.
Although this rule does not fall within the time window of rules that can be challenged by the new Congress under the Congressional Review Act, it can be revisited and repealed by HHS in a subsequent notice-and-comment rulemaking effort.
There are other ways that the Trump administration could change the landscape of reproductive health. However, most of them (like changes to Medicaid requirements and changes to basic coverage requirements under the Affordable Care Act) would require the passage of legislation. While Republicans will have control of the Executive Branch and likely both chambers of Congress, they will not have a filibuster-proof majority in the Senate, so any legislation would also require Democratic buy-in or a change of the rules by the Senate Majority Leader to eliminate the filibuster.
Final thoughts
As we stated at the outset, in the aftermath of the 2024 elections, when it comes to abortion and other reproductive health issues, much remains in flux. Reed Smith will continue to monitor developments with regard to the regulation of reproductive health. If you have questions please check the Reproductive Health Working Group and Resource Center on the firm’s website, or reach out to the Health Care attorneys at Reed Smith.
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